Nova Biomedical StatStrip Glucose Meter Recalled for Data Error
Nova Biomedical is recalling StatStrip Glucose meters due to a software defect that may assign patient test results to the wrong medical record.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality…"
Plain-English summary
Nova Biomedical Corporation is recalling 1,858 units of the StatStrip Glucose and B-Ketone meter, Model No. 63683. The recall covers software versions 0.00.13.10 through 1.5.14.25. The product was distributed nationwide in the US and in 22 foreign countries.
The recall is due to a software synchronization issue that causes the device to intermittently retain previously scanned barcodes, including patient identification and quality control codes. This defect can cause a current patient's glucose result to be incorrectly assigned to a previous patient's medical record, while the current patient's record remains without the result. This may lead to inappropriate clinical interventions, particularly for critically ill patients, neonates, and infants. The defect does not affect the analytical accuracy of the glucose measurements themselves.
Healthcare facilities and users should stop using the affected devices and contact Nova Biomedical Corporation for instructions on remediation or replacement.
The recalled product
- Product
- StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.
- Manufacturer
- Nova Biomedical Corporation
- Category
- Medical Device — Glucose Meter
- Affected units
- 1,858
Distribution
Distributed nationwide across the United States.
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